Overview

Genotype-guided Treatment in PTCL

Status:
Not yet recruiting
Trial end date:
2026-12-15
Target enrollment:
0
Participant gender:
All
Summary
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ruijin Hospital
Collaborators:
Nanfang Hospital of Southern Medical University
Peking University People's Hospital
Sun Yat-sen University
Tongji Hospital
West China Hospital
Treatments:
Azacitidine
Criteria
Inclusion Criteria:

- Histologically-confirmed Peripheral T-cell lymphoma

- Availability of archival or freshly collected tumor tissue before study enrollment

- Evaluable lesion by PET-CT or CT scan

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

- Life expectancy greater than or equal to (>/=) 3 months

- Informed consent

Exclusion Criteria:

- Patients with central nervous system (CNS) lymphoma

- History of malignancies except for basal cell or squamous cell carcinoma of the skin
or carcinoma in situ of the cervix

- Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders,
connective tissue diseases, serious infectious diseases and other diseases

- Laboratory measures meet the following criteria at screening (unless caused by
lymphoma):

Neutrophils<1.0×10^9/L Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow
involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and
bilirubin are 1.5 times higher than the ULN.

Creatinine is 1.5 times higher than the ULN.

- HIV-infected patients

- Active hepatitis infection

- Patients with psychiatric disorders or patients who are known or suspected to be
unable to fully comply with the study protocol

- Pregnant or lactation

- Other medical conditions determined by the researchers that may affect the study For
T3 should exclude patiens with active autoimmune disease